Clinical trial · Interventional
Deferasirox for Treating Patients Who Have Undergone Allogeneic Stem Cell Transplant and Have Iron Overload
Deferasirox Treatment and Labile Plasma Iron in Iron Overloaded Patients Who Have Undergone Allogeneic Hematopoietic Stem Cell Transplantation
NCT01159067CI-TRIAL-00039117terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low enrollment
Summary
Brief summary (as posted)
RATIONALE: Low dose deferasirox may be safe and effective in treating patients who have undergone hematopoietic stem cell transplant and have iron overload. PURPOSE: This pilot clinical trial studies safety and tolerability of deferasirox in hematopoietic stem cell transplant recipients who have iron overload. Effect of low dose deferasirox on labile plasma iron is also examined.
Conditions
Conditions (102)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Accelerated Phase Chronic Myelogenous Leukemia | Accelerated Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Adult Acute Lymphoblastic Leukemia in Remission | Adult Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
| Adult Acute Myeloid Leukemia in Remission | Adult Acute Myeloid Leukemia | CURATED_BROADER | 0.78 |
| Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities | — | UNRESOLVED | — |
| Adult Acute Myeloid Leukemia With Del(5q) | Acute Myeloid Leukemia with del(5q) | ONTOLOGY_EXACT | 0.85 |
| Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) | — | UNRESOLVED | — |
| Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| deferasirox | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive oral deferasirox once daily for up to 6 months in the absence of unacceptable toxicity.
- interventionNames
- Drug: deferasirox
Primary outcomes (1)
- measure
- Number of Patients With Elevated Labile Plasma Iron (LPI) Above Threshold (0.5 Umol/L)
- timeFrame
- At baseline
Secondary outcomes (3)
- measure
- Number of Patients With LPI Below 0.5 Umol/L After Treatment
- timeFrame
- Assessed through 6 months from the start of treatment
- description
- In patients with LPI values above threshold 0.5umol/L at baseline, number of patients had LPI suppressed below this value after treatment. Measurement of LPI is done on plasma specimens.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion * Patients must have undergone a matched related donor, matched unrelated donor or cord blood Hematopoietic Stem Cell Transplant (HSCT) over 6 months ago * Patients currently on Desferal (desferrioxamine) therapy will require a one day wash out prior to the first dose of study drug * Serum ferritin \>= 1500 ng/mL on two occasions two weeks apart at screening; samples must be obtained in the absence of concomitant infection * Normal C-reactive protein level at screening * Patients must be red cell transfusion independent for 2 months prior to enrollment * Sexually active women must use an effective method of contraception, or must have undergone clinical documented total hysterectomy and/or oophorectomy, or tubal ligation or be postmenopausal (defined as amenorrhea for at least 12 months) * Written informed consent by the patient Exclusion * Chronic hepatic GVHD with serum total bilirubin over 2 mg/dL * Known hypersensitivity to deferasirox * Serum creatinine above the upper limit of normal * AST or ALT \> 200 U/L during screening * Clinical or laboratory evidence of active Hepatitis B or Hepatitis C (HBsAg in the absence of HBsAb OR HCV Ab positive with HCV RNA positive and ALT above the normal range) * History of HIV positive test result (ELISA or Western blot) * History of drug or alcohol abuse within the 12 months prior to enrollment * ECOG Performance Status \> 2 * Patients with a diagnosis of or history of clinically relevant ocular toxicity related to iron chelation * Systemic diseases (cardiovascular, renal, hepatic, etc.) which would prevent study treatment * Pregnancy (as documented in required screening laboratory test) or breast feeding * Patients who received treatment with systemic investigational drug within the past 4 weeks or topical investigational drug within the past 7 days or are planning to receive other investigational drugs while participating in the study * Other surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of study drug * History of non-compliance to medical regimens or patients who are considered potentially unreliable and/or not cooperative
References
Publications (0)
Data not yet available
No reference posted for this study.